CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:June 27, 2018
End Date:May 13, 2022
Contact:Vanessa Esquibel
Email:vesquibel@bioatla.com
Phone:858-263-1598

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A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety,
tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active
biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2- ADC) in patients with
advanced solid tumors. This study will consist of a dose escalation phase and a dose
expansion phase.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed locally advanced
unresectable or metastatic solid tumor and have failed all available standard of care
(SoC) therapy and for whom no curative therapy is available or who are not eligible,
intolerant to or refuse standard therapy.

- Patients must have measurable disease.

- For the dose expansion phase: Patients with locally advanced unresectable or
metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC)
and soft tissue sarcoma (STS)

- Age ≥ 18 years.

- Adequate renal function

- Adequate liver function

- Adequate hematological function

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least three months.

Exclusion Criteria:

- Patients must not have clinically significant cardiac disease.

- Patients must not have known non-controlled CNS metastasis.

- Patients must not have received granulocyte colony stimulating factor (G-CSF) or
granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3021
administration.

- Patients must not have had prior therapy with a conjugated or unconjugated auristatin
derivative/vinca-binding site targeting payload.

- Patients must not have Grade 2 or higher peripheral neuropathy.

- Patients must not have known human immunodeficiency virus (HIV) infection, active
hepatitis B and/or hepatitis C.

- Patients must not be women who are pregnant or breast feeding.
We found this trial at
8
sites
1800 North Williams Street
Denver, Colorado 80218
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Phone: 503-418-9324
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Aurora, Colorado 80045
Principal Investigator: Anthony Elias, MD, PhD
Phone: 720-848-0669
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Houston, Texas 77030
Principal Investigator: Siqing Fu, MD
Phone: 713-792-9869
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Houston, TX
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Howard Burris, MD
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Tampa, Florida 33612
Principal Investigator: Mihaela Druta
Phone: 813-745-2025
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Tampa, FL
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